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Compliance of Laboratory Suppliers with GLP Principles - PharmaFacts
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Compliance of Laboratory Suppliers with GLP Principles

Guidances - OECD Guidances

The responsibilities of the management of test facilities are defined in the OECD Principles of Good Laboratory Practice1 under the heading of Test Facility Organisation and Personnel (Section II.1). Test facility management should ensure that the GLP Principles are complied with at the test facility and that a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of the study. They also should ensure that test facility suppliers meet requirements
appropriate to their use in a study. On the basis of these requirements, suppliers of materials used in studies submitted to regulatory authorities need not be included in national GLP compliance programmes but they do play a definite role relating to the responsibilities of the  management of test facilities.

As by definition in the GLP Principles, the responsibility for the quality and fitness for use of equipment and materials rests entirely with the management of the test facility. The acceptability of equipment and materials in GLP-compliant laboratories should therefore be guaranteed to any regulatory authority to whom studies are submitted. The main purpose of this document is to offer advice to both test facility management and suppliers as to how they might meet GLP requirements through national  accreditation schemes and/or working to formal national or international standards, or by adopting other measures which may be appropriate to a particular product. National or international standards, which may be set by an accreditation organisation, may be applied whenever they are acceptable to the test facility’s management. The management of facilities, individually or in co-operation with each other, should thus maintain close contacts with  suppliers and with their accreditation organisations.